Trials / Completed
CompletedNCT01968018
A Study of Safety and Effectiveness of Ultracet in Patients With Chronic Cancer Pain
A Study of Safety and Efficacy of Ultracet in Patients With Chronic Cancer Pain
- Status
- Completed
- Phase
- Phase 4
- Study type
- Interventional
- Enrollment
- 35 (actual)
- Sponsor
- Janssen-Cilag Ltd.,Thailand · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the analgesic (painkiller) effectiveness and safety of combination of tramadol HCI (37.5 mg)/acetaminophen (325 mg) in the treatment of chronic cancer pain.
Detailed description
This is an open-label (all people know the identity of the intervention) study. A total of 35 participants will be enrolled in this study. Participants will receive tablet of combination of tramadol HCI (37.5 mg)/acetaminophen (325 mg) on Day 1. Participants may increase their daily dosage of study medication as 1 to 2 tablets every 4 to 6 hours as needed for pain relief, up to maximum of 8 tablets per day. Rescue medication consisting of Extra Strength Tylenol (500 mg) 2 tablets daily for the first six days of the Open-label Phase will be allowed so that the total daily dose of acetaminophen will not exceed 4,000 mg. The total duration of the study treatment for each participant will be approximately 6 weeks. Safety will be evaluated by assessment of adverse events, clinical laboratory tests, skin site assessments, vital signs, and physical examination which will be monitored throughout the study.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tramadol HCI/acetaminophen | Participants will receive tablet of tramadol HCI (37.5 mg)/acetaminophen (325 mg) on Day 1. Participants may increase their daily dosage of study medication is 1 to 2 tablets every 4 to 6 hours as needed for pain relief up to maximum of 8 tablets per day. |
Timeline
- Start date
- 2004-07-01
- Primary completion
- 2007-04-01
- Completion
- 2007-04-01
- First posted
- 2013-10-23
- Last updated
- 2013-10-23
Locations
1 site across 1 country: Thailand
Source: ClinicalTrials.gov record NCT01968018. Inclusion in this directory is not an endorsement.